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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034013
Receipt No. R000038754
Scientific Title Human monitor test of Spanish extra virgin olive oil derived from Picual species
Date of disclosure of the study information 2018/09/03
Last modified on 2019/03/05

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Basic information
Public title Human monitor test of Spanish extra virgin olive oil derived from Picual species
Acronym Human monitor test of Spanish extra virgin olive oil derived from Picual species
Scientific Title Human monitor test of Spanish extra virgin olive oil derived from Picual species
Scientific Title:Acronym Human monitor test of Spanish extra virgin olive oil derived from Picual species
Region
Japan

Condition
Condition Healthy subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to examine the influence on blood properties by continuously ingesting test foods for 4 weeks for healthy Japanese males and females ages 20 to 65 years old.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood BDNF
Key secondary outcomes Serum lipids, Amyloid beta(1-40, 1-42)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 4-week intake of the test food
Wash out
4-week intake of the placebo
Interventions/Control_2 4-week intake of the placebo
Wash out
4-week intake of the test food
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1)Japanese males and females aged 20 to 65 years when informed concent.
2)Subjects who can continuously drink test for 4 weeks.
3)Subjects who got an explanation about the purpose and content of the research and obtained written consent.
Key exclusion criteria 1)Subjects with or who have a history of diseases such as diabetes mellitus, liver disease, kidney disease, or heart disease.
2)Currently, exercise therapy and diet therapy are performed under the supervision of a physician.
3)Subjects with diseases requiring continuous medication
4)Subjects with a history of drug or food allergy
5)Subjects who consume olive oil continuously
6)Subjects who have a history of cholelithiasis
7)Subjects who have participated in other human clinical studies within the past 3 months or are expected to participate in other human clinical studies during the study period.
8)Other than the above, the principal investigator judged the subject to be inappropriate.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takayuki Nakano
Organization Kagoshima Immaculate Heart University
Division name Department of Health and Nutrition, Faculty of Nursing and Nutrition
Zip code
Address 2365 Amatatsu, Satsuma-sendai, Kagoshima, 895-0011, Japan
TEL 0996-23-5311
Email nakano@jundai.k-junshin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takayuki Nakano
Organization Kagoshima Immaculate Heart University
Division name Department of Health and Nutrition, Faculty of Nursing and Nutrition
Zip code
Address 2365 Amatatsu, Satsuma-sendai, Kagoshima, 895-0011, Japan
TEL 0996-23-5311
Homepage URL
Email nakano@jundai.k-junshin.ac.jp

Sponsor
Institute Kagoshima Immaculate Heart University
Institute
Department

Funding Source
Organization Hioki city
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 03 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 07 Month 24 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 03 Day
Last modified on
2019 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038754

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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